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(Some Guy)   FDA: "Your products are drugs and therefore they may not legally be marketed without an approved new drug application." Are they talking about: A: Hemp? B: Untested medicine? or C: Walnuts?   (worldtruth.tv) divider line 172
    More: Asinine, FDA, drug applications, coronary artery disease, cancer types, HDL, Dietary mineral, investments, Frito-Lay  
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14691 clicks; posted to Main » on 25 Feb 2013 at 3:14 PM (1 year ago)   |  Favorite    |   share:  Share on Twitter share via Email Share on Facebook   more»



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2013-02-25 04:47:06 PM  

J. Frank Parnell: But if you want to rush a drug to market for something like 'restless leg syndrome' with hardly any testing the FDA has your back.

/If it's found to be fatal later, that's just the price you pay for progress.


I am really getting sick of people acting like "Restless Leg Syndrome" is some type od big joke/scam

your legs are not Restless because they will not stop moving, they are restless because you hope you can find some combo of movement and postion that they will at last be conferable and you can sleep for a few hours before they wake you back up

///This is the reason your grandfather would do a shot before he went to bed
 
2013-02-25 04:51:33 PM  
We need to identify these useless crats and sue the government to have them fired.  They waste tax payer money and provide nothing but bad will to the public.
 
2013-02-25 04:54:31 PM  
 Yet another example of how modern regulatory agencies exsist only to protect and facilitate the industries they're supposed to regulate. Pharmaceutical companies had been pushing pretty hard for them to crack down on truthful health claims for a long time. Hell at one point they had lobbied for some common plants and foods to be "better regulated" becauses they provided long proven medical benifits but were forced to back down once enough people called BS on it.

Hypnozombie
/hey wait, I hear there are all kinds of medical benifits from drinking water... oh damn.
 
2013-02-25 04:54:48 PM  

loki see loki do: WinoRhino: loki see loki do: WinoRhino: loki see loki do: Model 8 motherfarking sixteen, yo.

Is that the one with the attractive wooden base?

Damn straight.

Here's the thing with that particular model. One Christmas Eve I'm drinking martinis, I'm cracking nuts, smoking a little of the haze, right? I start to bug out a bit. The Christmas tree starts growing, I'm shrinking and all these army mice come out of nowhere led by this, like, mouse king I guess. At that point I'm calling at the ol' model 816 to help me out, right? Nutcrackers are supposed to fight this shiat off. But no. He's all "Look, I have an attractive wooden base!" Not legs, mind you, like a proper nutcracker. No bayonet. No intimidating red uniform. He's just wagging his wooden handle like a scared puppy. I had to fight off the mice creatures with a goddamned sword swizzle stick, and it was a biatch to get that olive off first. I finish off the mouse king, suffer a few bites, possibly rabies, all while the 816 just apologizes and offers me a goddamned filbert. fark the model 816 and its attractive wooden base. I regifted that biatch the next morning.

You must have been trippin balls, holmes, cause the 8 motherfarking 16 has your back. Remeber, this is the ROCKET 816, and if you do not avail yourself of its formidable leverage, which is capable of exerting metric farkloads of gleaming alloy crunch death on invading mousies, all you need to do is unscrew the bustanut reciever and the Rocket 8 mousestomping 16 can turn a standard pecan or brazil nut into a high velocity shrapnel hail .

You'll rue that regifting, bub.


I think I've seen that missing Rocket 816-my future father in law has that bad boy. He bought it at a yard sale from a widow-she was scared of it, even though her departed old man had added a wicked nut catcher base to it, so you can let the Rocket fly for an hour and not even get a shell on the tabel. Didn't know what she had-that puppy now had a place of honour in the FFIL's living room, right next to his chair. Guy's heavy duty mechanic, I figure it's a matter of time before I come by and there's a log splitter in its place.
 
2013-02-25 04:55:10 PM  
FDA  www.pacovilla.com  BIG RX
 
2013-02-25 04:56:06 PM  

Revek: We need to identify these useless crats and sue the government to have them fired.  They waste tax payer money and provide nothing but bad will to the public.


because it is so Evil to say

"If you are going to say your product has medical benefits, you need to be prepared to prove it"
 
2013-02-25 04:56:56 PM  

Ehcks: J. Frank Parnell: But if you want to rush a drug to market for something like 'restless leg syndrome' with hardly any testing the FDA has your back.

/If it's found to be fatal later, that's just the price you pay for progress.

"Restless leg syndrome" is about as real as Morgellons. Curing a fake disease is impossible. The FDA doesn't regulate obviously impossible claims.


lewl
 
2013-02-25 05:00:37 PM  

lostcat: Wow, a massive page full of mysql warnings.


upload.wikimedia.org
 
2013-02-25 05:04:24 PM  

DoBeDoBeDo: Hey FDA, how about getting on approving better treatments for DVT?   I'm tired of watching my vitamin K intake and testing my blood all the time.  You've already approved them for A Fib, just check the little box for DVT so my docs will presecribe them.


I have A-Fib. Many people are happy with Pradax, but a word of caution: I was on Pradax for several months and the stomach pains were nearly unbearable. Pradax is an acid pill that you have to take twice a day, so, if like me, you have a sensitve stomach you might want to a have a thorough discussion with your doctor before going on it.

Xarelto, on the other, hand is a tiny non-acidic pill that you only take once a day.  For me it has proven .the best choice, no contest.
 
2013-02-25 05:15:09 PM  

thenumber5: J. Frank Parnell: But if you want to rush a drug to market for something like 'restless leg syndrome' with hardly any testing the FDA has your back.

/If it's found to be fatal later, that's just the price you pay for progress.

I am really getting sick of people acting like "Restless Leg Syndrome" is some type od big joke/scam

your legs are not Restless because they will not stop moving, they are restless because you hope you can find some combo of movement and postion that they will at last be conferable and you can sleep for a few hours before they wake you back up

///This is the reason your grandfather would do a shot before he went to bed


Why don't you just take a shot before bed, then? ;)
 
2013-02-25 05:31:37 PM  
If you market something as having curative properties, it becomes a drug in the eyes of the FDA. This is a Good Thing (TM). It prevents the resurgence of the snake-oil industry. Obviously many food items have various health benefits, and it is not illegal to point that out. However, it is the job of the public to educate themselves about what they put in their bodies. Or have we dropped to the level that we get all our information from the marketing departments of large corporations? Oh right... I guess we have.
 
2013-02-25 05:32:33 PM  
The FDA is full of people too wimpy to work for the Oregon Liquor Control Commission.
 
2013-02-25 05:34:58 PM  

Snargi: Here is another site with the same story that isn't Farked...Yet.

http://articles.mercola.com/sites/articles/archive/2012/03/07/fda-sa ys -walnuts-are-drugs.aspx


"As unbelievable as it sounds, current law makes it illegal for food producers to share certain types of scientific information with you."

Yeah, 'certain types' like 'made-up', 'highlyexaggerated' and 'baseless'.
 
2013-02-25 05:38:41 PM  

Revek: We need to identify these useless crats and sue the government to have them fired.  They waste tax payer money and provide nothing but bad will to the public.


I absolutely LOVE it when someone walks in, strolls past 100 opposition comments, and posts a short comment glad-handing the article.
 
2013-02-25 05:42:27 PM  

HypnozombieX: Yet another example of how modern regulatory agencies exsist only to protect and facilitate the industries they're supposed to regulate. Pharmaceutical companies had been pushing pretty hard for them to crack down on truthful health claims for a long time. Hell at one point they had lobbied for some common plants and foods to be "better regulated" becauses they provided long proven medical benifits but were forced to back down once enough people called BS on it.

Hypnozombie
/hey wait, I hear there are all kinds of medical benifits from drinking water... oh damn.


Yes they are in bed together but at a minimum the FDA does require even big pharma to back up their claims, sure the side affects will melt you like the robocop dude but at least you don't have the restless leg!
 
2013-02-25 05:48:16 PM  

J. Frank Parnell: ga362: Walnut oil cured ringworm when I was a kid.

You need FDA approval to say that.


No. You need FDA approval to make money from selling it.
 
2013-02-25 05:51:15 PM  

Mr_Fabulous: J. Frank Parnell: ga362: Walnut oil cured ringworm when I was a kid.

You need FDA approval to say that.

No. You need FDA approval to make money from selling it.


Yup and stick it in a tiny bottle & overcharge for it.
 
2013-02-25 06:15:37 PM  
What about Chin-nuts?
 
2013-02-25 06:37:49 PM  
McCain? John McCain?

Anyone?

/fark, I am disappoint
 
2013-02-25 06:43:16 PM  
benzedrex aka OTC methamphetamine??
 
das
2013-02-25 06:58:22 PM  
Good. I hate walnuts.

grumpycat.jpg
 
2013-02-25 06:58:57 PM  

HindiDiscoMonster: /there is something white and sticky on your chin btw...


The article is a paranoid conspiracy site complaining about the FDA telling a food company they aren't allowed to make factual medical claims without FDA approval.

The FDA isn't exactly shiatting rainbows, but it seems that conservatives only REALLY get upset at them when they actually do their jobs and violate the freedom of businesses to lie to consumers.
 
2013-02-25 07:09:35 PM  

HindiDiscoMonster: Diamond didn't say "we say this is true", they said: "These studies say this is true."



According to some, there are "studies" that say homeopathic sugar pills will slow aging, cure cancer, regrow lost limbs, and bring the dead back to life.

But even if said studies do exist, that doesn't make them accurate, nor sufficient evidence to get a pass from the FDA.
 
2013-02-25 07:10:40 PM  

HindiDiscoMonster: Diamond didn't say "we say this is true", they said: "These studies say this is true."


That's pretty firmly in the FDA's neighborhood.  By the way, let's pour one out for the poor, poor marketers, shall we?

Every pseudo-medicine out there has claims that multiple studies support them. There are rules about what you're allowed to present to consumers as medical fact without the FDA disclaimer, and Diamond's marketers knew what they were. If they didn't, they're terrible at their jobs.
 
2013-02-25 07:20:16 PM  

HindiDiscoMonster: Diamond made NO claims.
Diamond cited studies that made claims


"On its website and packaging, the company stated that the omega-3 fatty acids found in walnuts have been shown to have certain health benefits, including reduced risk of heart disease and some types of cancer."

That's not a citation. That's using the existence of un-cited studies to make a medical claim. If it's not an FDA-approved one, you're not allowed to do that.

The FDA maintains a list of qualified and unqualified health statements that are acceptable for use in advertisements. They're A-OK with the claim that Omega 3s improve hearth health (depending on how it's phrased), but as far as I know they don't allow advertisements to claim that Omega 3s "Treat, cure, or prevent" any variety of cancer.
 
2013-02-25 07:28:33 PM  

HindiDiscoMonster: regardless, discredit the studies if you have a problem with them, but leave Diamond alone... they made NO claims.



Which studies did they cite?

If they had said "According to a study by Doctor Roberts at John Hopkins...", that would be a verifiable claim by a recognized institution.

Instead, their claim is basically "According to Wikipedia, 35 guys in lab coats said..."
 
2013-02-25 07:29:04 PM  
Why is the article text centered?
 
2013-02-25 07:36:53 PM  

stonicus: Food, it prevents/cures starvation!

Now all food is a drug...


Great now you need a prescription to buy groceries
 
2013-02-25 07:37:35 PM  

the ha ha guy: If they had said "According to a study by Doctor Roberts at John Hopkins...",


That's actually not allowed either, at least on advertising information.

It's not like they'd be publishing the abstract of the study. They'd be providing a (vested) lay person's analysis of whatever the best-case scenario of the study is (from the perspective of their bank account).

Study:
Out of 4,000 rats, 100 on placebo developed cancer, but only 75 given Walnuts did- we recommend further study

Ad:
Johns Hopkins recently published a study DEFINITIVELY PROVING THE CANCER-CURING POWER OF WALNUTS, WHICH WE SELL
 
2013-02-25 07:39:48 PM  

HindiDiscoMonster: if you don't see the problem with labeling a farking walnut as a new "drug", then there is no help for you. it is a patently false claim which is made apparent by the fact that they allow junk food to have a heart healthy label at the same farking time.


The FDA is 100% within their power to treat the product as an unapproved medical supplement, because that's how Diamond decided to market it.

If you want to sell nuts hassle-free, don't spend millions of dollars telling people they cure diseases.
 
2013-02-25 07:43:03 PM  

HindiDiscoMonster: oh, i can see the packaging now... 285 pages of citations attached to the packaging... won't that be great for the price of walnuts? $18.00 for packaging alone... great idea.



They don't have to provide the list on the packaging, they only have to make it available somewhere.

So far, they haven't even done that, they only cite "stuff we found in some library" and "a tabloid-quality alternative health magazine", neither of which are verifiable claims.

And in any case, you asked me to disprove the studies, yet you refuse to let me see those studies. Do you really not see the flaw in that argument, or are you just making a lazy attempt at trolling?
 
2013-02-25 07:50:14 PM  
C:) Subby is a Person of drug company, the answer is c:) money.
 
2013-02-25 07:51:01 PM  
Andy Murray's Bald Spot:

[www.d.umn.edu image 350x257]
We know your game.


That movie actually had a several key inaccuracies.

1) you do not get glycerine by rending fat (human or otherwise).  Glycerine is a byproduct of the chemical process of soapmaking (called soponification).  Most commercial soapmakers separate out the glycerine by adding salt to the soap while it's still in a liquid or mushy form. handmade soap retains its glycerine which is very moisurizing.

2) if you do experience a lye burn do not, under any circumstances, pour vinegar  or any other acid on it. yes lye is an alkaline and vineger is an acid and the one will cancel out the other, but it will cause a LOT of bubbling and actually make the burn worse.  Always ALWAYS flush any chemicals from your skin or eyes with cold water.

Animal fat does make a very good bar of soap though (whether it be tallow or lard) but often carries with it a slightly porcine smell (in the case of lard) or a beefy smell (in the case of tallow).  You can combine several different plant oils to get a similar result without the odor.

Now ask me about lotions (I dare you).
 
2013-02-25 07:51:19 PM  
It's true. They are drugs.  I'm hooked on Blue Diamond Smokehouse Almonds
 
2013-02-25 07:52:00 PM  

HindiDiscoMonster: that ain't my job...

/google is your friend.



You claim that Diamond has cited verifiable studies. According to Google, they cite anonymous "studies" and vague "research", neither of which are verifiable by any metric.

So, you made the claim that they cite specific studies, therefore it is your job to prove your claim.
 
2013-02-25 07:53:45 PM  

rumpelstiltskin: fark you, marketers. There's nothing stupid about this particular law. Go think of some other way to sell your walnuts.




No!

I call for a war on walnuts!

If we can save just one child.
 
2013-02-25 07:57:25 PM  

rumpelstiltskin: fark you, marketers. There's nothing stupid about this particular law. Go think of some other way to sell your walnuts.


Done in one. Just because you want to sell shiat doesn't give you carte blanche to market pseudo-science and out-of-context half truths. 

/fark you, marketers.
//And fark you again for getting publicity for this contrived bullshiat.
 
2013-02-25 07:59:13 PM  

HindiDiscoMonster: read what i wrote again... and again if you still don't get it: i claimed only that they cited studies, not SPECIFIC studies. I also made no claim as to verifiability.



So you honestly think that "According to Wikipedia, some guy in a lab coat told a blogger" is sufficient to satisfy the FDA about specific health claims?
 
2013-02-25 07:59:27 PM  
I hate food lobby groups.

Fark Pistachios.
Fark Walnuts.
Fark Florida Oranges.
Fark The Other White Meat.
Fark the Incredible Edible Egg.
And double fark the American Dairy Council.

/I probably missed a few.
//I just needed to vent.
 
2013-02-25 08:08:12 PM  

HindiDiscoMonster: This in no way constitutes an authorization to take artistic license in what i said. Please look up the words that i used at Dictionary.com or a similar source, then try to read it without those artistic glasses on. If I make a claim, I will be VERY clear in said claim.

/or i will be a smartass



I wasn't referring to your claims, I was referring to the claims made by Diamond, which currently consist of "studies on file in a library" and "studies published by a supermarket tabloid".

In any case, Diamond is required to provide legitimate studies to the FDA upon request. Apparently, they refuse to do so, thus the action being taken by the FDA.
 
2013-02-25 08:13:00 PM  

Curt Blizzah: What about Chin-nuts?


they cure hysteria
 
2013-02-25 08:18:48 PM  

Jument: Aigoo: Right then. So who wants to sue the shiat out of PepsiCo for the blantantly fraudulent implications and claims it makes saying it'll lower your cholesterol and prevent heart disease to eats bags and bags of their heart-healthy chips? Surely that's fraud?

I'm curious, what products are you talking about?
Personally I am fine with the FDA cracking down on advertising and packaging that suggests health benefits based on nothing.


Why don't you go have a look at the Frito Lay site (they're owned by Pepsi)? Or look at a package. Both strongly imply that they're healthy for you--0 transfats! Use only oils that are good and lower LDL (bad cholesterol) while maintaining HDL (good cholesterol)! All natural ingredients (um...potato chips should only have potatoes, oil, and salt...any chip can say that, it doesn't make it good for you). Their website has an entire secion dedicated to "your health."

Don't believe me they make these claims? Go look. Here's a direct quote from the website:

Frito-Lay snacks start with real farm-grown ingredients.  You might be surprised at how much good stuff goes into your favorite snack. Good stuff like potatoes, which naturally contain vitamin C and essential minerals. Or corn, one of the world's most popular grains, packed with Thiamin, vitamin B6, and Phosphorous - all necessary for healthy bones, teeth, nerves and muscles.

And it's not just the obvious ingredients. Our all-natural sunflower, canola, corn and soybean oils are considered to be healthier oils by the FDA because they contain good polyunsaturated and monounsaturated fats, which help lower total and LDL "bad" cholesterol and maintain HDL "good" cholesterol levels. They also contain <20% of the bad saturated fat, which raises LDL, cholesterol and 0g of trans fat. Even salt, when eaten in moderation as part of a balanced diet, provides sodium which is essential for the body
.

They make those damn chips sound like farking health food, for the love of God! And the FDA lets them get away with it. Double standard. Pepsi should be held just as liable as Diamond, period, or Diamond should be allowed to state that many, many studies state the walnuts have these beneficial effects. Because fact is, walnuts are a goddamned health food compared to farking potato chips and cheetos.
 
2013-02-25 08:22:24 PM  

papafree: Aigoo: But walnuts... 50-some papers backing up the claims and no lobbyists. So sorry, walnuts.

Follow the money, honey.

Yes, follow the money. Big Walnut puts lots of cash into 50 studies that purport their super incredible awesome health benefits. That doesn't mean they're good studies, but at least they can claim persecution when FDA finds they're being incredibly dishonest by paying scientists to conduct studies that make their products look healthier than they actually are.

/Love walnuts. super tasty snack.


I don't disagree that walnuts probably paid for the studies. The same as the cereal companies paid for the studies saying that breakfast is the most important meal of the day. Like I said, follow the money.

You don't think Monsanto paid for the studies on corn and canola oil? you're kidding yourself.
 
2013-02-25 08:25:37 PM  
What is it with all the nut hate, farking nutists

I hope walnuts do prevent cancer and you all get nut cancer and your nuts fall off due to your raging nuthatred

/nuts to you
//nuts
 
2013-02-25 08:31:05 PM  

HindiDiscoMonster: now that is an entirely different issue... and THAT i agree with. What I do not agree with is trying to classify a nut as a drug.



They are not trying to classify all walnuts as a drug, only that specific product, with that specific packaging and advertising.

And even then, "classified as a drug" is merely an enforcement measure. If the FDA were to impose a small fine per infringement, the large corporations would pay it like a tax. If it were a large fine, the local/regional companies would be crippled over one honest mistake.

But under their current method, "if you call it a drug we treat it as a drug", everyone is treated equally under the law. Both small and large companies have a chance to retract or prove their claims. Only when the companies refuse do we even hear about it in the first place, as we're seeing here.

If Diamond had said "here are the reliable studies", the FDA would have backed off. If Diamond had said "we'll change our advertising", the FDA would have backed off. Instead, Diamond said "we're going to keep making our claims anyway because our studies say we can, but we're not going to let you see those studies that may or may not exist". Thus, the FDA is making them submit to the same standards as a drug manufacturer.
 
2013-02-25 09:27:56 PM  

HindiDiscoMonster: which indicates to me that these studies are well known...



Are they? One source is a tabloid, and the other is a library that accepts everything submitted.

Regardless, Diamond obviously knows the names of the studies, yet they refuse to cooperate with the FDA at all. They could have settled this long ago with a simple list, instead they're trying to martyr themselves in the eyes of the "deregulate medicine" community.

This isn't like a police officer pulling someone over for a miraculously "busted taillight" that was intact seconds before, this is like someone with no taillights at all using the defense of "my anonymous mechanic who lives in some state you've never heard of says I don't need taillights and you can't prove otherwise".
 
2013-02-25 09:53:00 PM  
I'll bite, all you restless leg syndrome haters. It's a real thing, I have it. At the same time, I agree that it definitely sounds like BS to someone who doesn't. I don't have it that bad. I'll go a month, two, maybe more without anything at all, then I'll have a rough week or two of maybe 10-15 minutes a night of my leg wanting to spasm, which I can usually get rid of by getting up and pacing around the room for a few minutes. Nothing too bad, definitely not enough to even think about braving the magic drugs that supposedly cure it, which mostly seem to cause side effects that I would consider way worse than the RLS. But it is a real thing, no matter how shady it sounds.
 
2013-02-25 09:57:16 PM  

HindiDiscoMonster: so, the FDA uses the same suspect data about omega-3 fatty acids? maybe it should fine itself then.



The FDA does allow specific claims about omega-3, but only from specific sources, which do not include walnuts. [1]

Since walnuts aren't on that list, Diamond has to cite their specific sources when asked. The rules are simple. If you say X cures Y, you must prove that X cures Y.

But despite the alleged prevalence of proof, Diamond is refusing to cite their claims at all. When the FDA gave them multiple avenues of becoming legal, Diamond decides to go with "help help I'm being repressed".
 
2013-02-25 09:59:48 PM  

Olfin Bedwere: center


Because whoever formatted it is overdue to be slapped with a large trout. Way overdue.
 
2013-02-25 10:01:48 PM  

HindiDiscoMonster: this is like someone with taillights using the defense of "my well known mechanic who lives in a different state says "my taillights are road legal in this state."



More like "my mechanic who lives somewhere in California but I will not name says..."

If they have the studies, they can name those studies. But what they're saying so far is "the studies are somewhere in that building, find them yourself".
 
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